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Annals of Oncology 15:45-50, 2004
© 2004 European Society for Medical Oncology


Original Paper

A phase II study of cisplatin and docetaxel administered as three consecutive weekly infusions for advanced non-small-cell lung cancer in elderly patients

Received 20 April 2003; revised 17 August 2003; accepted 28 August 2003

Background:

To evaluate the efficacy and safety of treatments for advanced non-small-cell lung cancer in elderly patients aged 75 years or older, we conducted a phase II study of cisplatin and docetaxel administered in three consecutive weekly infusions.

Patients and methods:

The eligibility criteria for the study included the presence of chemotherapy-naive advanced non-small-cell lung cancer, age ≥75 years, Eastern Cooperative Oncology Group performance status of 0 or 1, a measurable lesion, adequate organ functions and signed informed consent. The chemotherapy regimen consisted of cisplatin (25 mg/m2) and docetaxel (20 mg/m2) on days 1, 8 and 15 every 4 weeks.

Results:

Between February 2000 and March 2002, 34 elderly patients with non-small-cell lung cancer were enrolled in the study and 33 patients were treated. Two complete responses and 15 partial responses were obtained for an objective response rate of 52% in 33 treated patients. The median survival period was 15.8 months, and the 1-year survival rate was 64%. Toxicities were mild with no grade 4 toxicities. Only grade 3 leukopenia (6%), neutropenia (12%), anemia (3%), hyponatremia (3%) and nausea/vomiting (3%) were observed.

Conclusion:

Cisplatin and docetaxel administered in three consecutive weekly infusions was safe and effective for the treatment of elderly patients with chemotherapy-naive non-small-cell lung cancer.

Y. Ohe1,*, S. Niho2, R. Kakinuma2, K. Kubota2, H. Ohmatsu2, K. Goto2, H. Nokihara1, H. Kunitoh1, N. Saijo1, H. Aono3, K. Watanabe3, M. Tango4, A. Yokoyama4 and Y. Nishiwaki2

1 Department of Internal Medicine, National Cancer Center Hospital, Tokyo; 2 Division of Thoracic Oncology, National Cancer Center Hospital, Kashiwa City; 3 Division of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, Yokohama; 4 Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan

Key words: cisplatin, docetaxel, elderly patients, non-small-cell lung cancer, weekly administration


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